Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Early/Mild to Moderate Stage knee osteoarthritis (KOA), as determined by Kellgren-Lawrence Grade 2 to 3 on PA standing radiograph within the past three months;

A prospective subject who has a diagnosis of non-end stage KOA (i.e., a potential study candidate) and expresses interest in participating but has no XRAY within the specified time-period will be sent for a fresh XRAY. This XRAY will be read by a radiologist & be paid for by the study.
>=40 years of age;

Average 100-point VAS score of >50, on average, within the past 3 months*, with KOA felt to be the primary contributor to pain.

Alternate 10-point scales with pain scores averaging >5 may be considered if the prospective subject also completes a VAS with score >50 at screening.
Exam consistent with KOA being primary etiology of pain;
No signs of inflammatory arthropathy in medical record, history or physical examination;
A >3 millimeter intra-articular (IA) effusion present on ultrasound evaluation.
[If a chronic liver or renal disease patient, evidence of stable disease over/within the past six months, else exclusion.]
Veteran receiving care at McGuire VAMC.

Exclusion Criteria:

Morbid obesity (BMI >40);
Poorly controlled diabetes (hemoglobin A1C > 7.5 or fasting blood glucose of >200) in last 6 months;
Ipsilateral knee surgery, trauma within last 6 months, or corticosteroid injection within 3 months.
4. History of inflammatory arthropathy (RA, SLE or crystalline arthritis of the knee)**;
Any rheumatoid arthritis or gout diagnosis is exclusionary.
Current infection of the affected joint or any other uncontrolled or untreated active infection.

Moderate to severe anemia (hemoglobin < 11 g/dl) or thrombocytopenia (platelet count < 100,000); Hemoglobin >17 g/dl or <11 g/dl and/or platelet counts >500,000 or <100,000 platelets/μl.

[CBC obtained within 6 months will be required, even if obtained at initial screening visit.]

Individuals on dialysis, with liver failure, or uncontrolled renal or liver disease are excluded.

In those with chronic renal or liver disease, documentation of stable disease within the most recent 6 months will be required.

Individuals on a therapeutic anticoagulant (e.g., Warfarin, Dabigatran, Enoxaparin) and those with a history of coagulopathy are excluded.

Per standard clinical practice, subjects on anti-platelet therapy are not excluded.

Pregnancy or breast-feeding;

Female subjects of child-bearing potential must have a negative pregnancy screen prior to enrollment.
Female subjects of child-bearing potential must confirm they are not actively breast-feeding prior to enrollment.
Current illicit drug abuse / active alcohol abuse (i.e, Current substance abuse);
Uncontrolled psychiatric disorder;
Lack of transportation (i.e., to get to/from appointments at VAMC) and/or willingness to attend study appointments (screening/consent, Intervention, Day10-follow-up, Month-6 follow-up, and then visits over-the-phone / in-person / or via Telehealth for Month-3 and Month-12;
Advanced or currently active cancer.
Blood disorders (such as Sickle Cell Anemia, TTP, others)
Vulnerable populations: Individuals incapable of making informed decisions will not be enrolled, nor will those under some form of incarceration.